Medication info
Artpe Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Artpe Tablets 10 mg (Donepezil Hydrochloride Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Donepezil Hydrochloride Hydrate›10.43mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201901648 · Approved 2019.03.19 · Insurance code 652904640

Summary

Main use
Improvement of symptoms of Alzheimer's disease
Who takes it
Adults · Children
Adult dose
As Donepezil Hydrochloride, administer 5 mg once daily before bed. For the first 4 to 6 weeks, maintain a dosage of 5 mg, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years of age who are underweight should not exceed 5 mg per day, and careful monitoring is necessary.
Child dose
There is no experience regarding the use in children.

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of symptoms of Alzheimer's disease

  • Symptoms of Alzheimer's disease
View approved original text

This medication is used to treat symptoms of Alzheimer's disease. It helps improve memory decline and cognitive function due to dementia, thereby enhancing the quality of life.

How to take

Adult dose

As Donepezil Hydrochloride, administer 5 mg once daily before bed. For the first 4 to 6 weeks, maintain a dosage of 5 mg, and after evaluating clinical response, it may be increased to 10 mg. When increasing to 10 mg per day, caution should be taken regarding gastrointestinal adverse reactions. Women over 85 years of age who are underweight should not exceed 5 mg per day, and careful monitoring is necessary.

Child dose

There is no experience regarding the use in children.

Precautions

This medication contains Donepezil Hydrochloride Hydrate as its active ingredient and is used for improving symptoms of Alzheimer's disease. This medication should not be administered to certain patients. For example, individuals with allergies to this medication or its ingredients, pregnant women or women who may become pregnant, breastfeeding women, and individuals with lactose intolerance or specific genetic metabolic disorders should not take this medication. Patients with heart disease or heart conduction disorders should be cautious when using this medication, as there is a possibility of heart problems such as bradycardia or arrhythmia. Individuals taking non-steroidal anti-inflammatory drugs or with a history of peptic ulcers should use this medication with caution due to the risk of gastrointestinal bleeding or exacerbation of ulcers. Patients with a history of asthma or obstructive pulmonary disease should be careful, as symptoms may worsen due to bronchoconstriction and increased mucus secretion. Patients with extrapyramidal disorders such as Parkinson's disease may experience worsening of their symptoms. Moreover, individuals allergic to the coloring agent Yellow No. 5 included in this medication should also be careful. This medication can cause various adverse effects, and in severe cases, heart problems, gastrointestinal bleeding, liver dysfunction, neurological issues, muscle problems, difficulty breathing, pancreatitis, kidney failure, and sudden death have been reported. Commonly, symptoms such as nausea, vomiting, diarrhea, headache, dizziness, insomnia, and fatigue may occur. Regular evaluation of therapeutic effects and side effects should be conducted during the use of this medication, and if there is no effect or if side effects are severe, the medication may be discontinued. This medication can affect heart rhythms, so individuals with a history of heart diseases or abnormal ECGs require special monitoring and investigation. Additionally, this medication may enhance gastric acid secretion and increase gastrointestinal motility, potentially worsening symptoms of peptic ulcers, so caution is advised for those with a history of gastrointestinal diseases. Caution is also needed for driving or operating machinery due to the possibility of dizziness or fatigue from taking this medication. Pregnant or breastfeeding women should generally avoid using this medication, and if necessary, consulting a specialist is essential. The safety for use in children has not been established, so it should not be used in this population. This medication is metabolized in the liver, hence patients with impaired liver function should be cautious, and interaction with other medications is possible, so any current medications should be disclosed to the doctor. In cases of overdose, symptoms such as nausea, vomiting, severe muscle weakness, and difficulty in breathing may occur, and immediate medical attention is needed. This medication should be kept out of the reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor (severe allergic reactions), high fever with severe rash, blisters, skin peeling, pain in oral/ocular mucosa (severe skin reactions), shortness of breath or difficulty in breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy (liver issues), sudden and very severe headache

Mild side effects

Nausea, vomiting, diarrhea, loss of appetite, insomnia, drowsiness, dizziness, headache, fatigue, tremors, sweating, skin rash, itching, muscle pain, incontinence, urinary disorders, edema, anxiety, hallucinations, aggressive behavior, confusion, delusions, drowsiness, increased blood pressure, palpitations, hypertension, hypotension, atrial fibrillation, QT interval prolongation on ECG, motor impairment, ataxia, voice changes, blood abnormalities (anemia, leukopenia, thrombocytopenia, etc.), abdominal pain

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help preserve the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.